UMIN-CTR Clinical Trial

Basic information
Public title	A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Acronym	A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Scientific Title	A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Scientific Title:Acronym	A phase I/II trial of concurrent thoracic radiotherapy with the combination of cisplatin and nab-pacliaxel for locally advanced non-small cell lung cancer
Region	Japan

Condition
Condition	locally advanced non-small cell lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine the recommended dose and assess the efficacy and safety of chemoradiotherapy with cisplatin plus nab-paclitaxel in patients with locally advanced non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	phase 1:determine the recommended dose phase 2:2year survival rate
Key secondary outcomes	phase 1:safety, response rate, 2year survival rate, progression free survival, completion rate of chemoradiotherapy phase 2:safety, response rate, progression free survival, completion rate of chemoradiotherapy

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemoradiotherapy: Combination of cisplatin plus nab-paclitaxel with concurrent thoracic radiotherapy 2Gy/day for 30 times Consolidation therapy: Combination of cisplatin plus nab-paclitaxel
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Cytologically or histologically documented non-small cell carcinoma of the lung. 2) Previously untreated Stage IIIA or IIIB 3) Unresectable 4) An approval of a radiotherapist by CT simulation based on the restriction of this protcol before registration. 5) Have measurable lesion 6) Patient aged 20-74 years old at the time of consent. 7) Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0~1 8) Have adequate organ function within two week before study entry 9) Have signed an informed consent document
Key exclusion criteria	1) Pulmonary disorder (idiopathic pulmonary fibrosis, interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.). 2) SVC syndrome 3) With active infection 4) With active double cancer. 5) With other serious disease condition (bleeding, cardiac diseases, poorly controlled diabetes, etc.) 6) Clinically significant drug allergy 7) Patients with steroid treatment. 8) Uncontrolled psychiatric disease. 9) Pregnancy or lactating patients 10) Positive serum HBs antigen or HCV antibody 11) Others
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Kazuhiko Middle name Last name Nakagawa
Organization	Kindai University Faculty of Medicine
Division name	Department of Medical Oncology
Zip code	5898511
Address	377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Email	nakagawa@med.kindai.ac.jp

Public contact
Name of contact person	1st name Hidetoshi Middle name Last name Hayashi
Organization	Kindai University Faculty of Medicine
Division name	Department of Medical Oncology
Zip code	5898511
Address	377-2 Ohno-higashi, Osaka-Sayama, Osaka
TEL	0723-66-0221
Homepage URL
Email	hidet31@gmail.com

Sponsor
Institute	Department of Medical Oncology, Kindai University, Faculty of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of the Faculty of Medicine of the University of Kindai
Address	377-2 Ohno-higashi, Osaka-Sayama, Osaka
Tel	0723-66-0221
Email	zizen@med.kindai.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	近畿大学医学部附属病院　腫瘍内科、市立岸和田市民病院　腫瘍内科、関西医科大学附属枚方病院　呼吸器腫瘍内科、倉敷中央病院　呼吸器内科、大阪医科大学付属病院　呼吸器内科

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 09 Day
Date of IRB	2013 Year 12 Month 05 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 12 Month 09 Day
Last modified on	2019 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014660